BEUDAMED
    FDA Recall Terminated

    Desktop Pro 4.2, 5.0, 5.1, 6.0, 6.2 A user interface of rthe SL/SLi Series Linear Accelerators that are used for radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner.

    Recall: Z-1555-2011 · Initiated August 23, 2007

    Recall

    Recall Number
    Z-1555-2011
    Event Number
    57688
    Firm
    Elekta, Inc.
    FEI Number
    1037831
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 23, 2007
    Posted
    March 4, 2011
    Terminated
    April 7, 2011
    Address
    4775 Peachtree Industrial Blvd, Bldg 300 # 300, Norcross, GA, 30092-3011

    Description

    Desktop Pro 4.2, 5.0, 5.1, 6.0, 6.2 A user interface of rthe SL/SLi Series Linear Accelerators that are used for radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner.

    Reason

    Under certain conditions it has been found that movement of the collimators can be induced during multi segment beams such as IMRT and Omniwedge which will not be detected by the Desktop Pro if high values are sent within the iCom tolerance table.

    Action

    The firm, Elekta, sent an "Important Notice A302" dated August 23, 2007 titled "Update to iCom Tables for Desktop Pro when used with Third Party R&V Systems",to all affected customers. On September 28, 2007, Elekta issued a second Important Notice A304 which reiterated the same information as was in Important Notice A302. The notices described the product, problem and actions to be taken. This notice provides a workaround on how to avoid the issue. In order to avoid this issues documented, Elekta recommended that the customers set the tolerance for collimators in the iCom tolerance table to be 3.0 degrees-no less than 3.0 and to use the Linac Record, if configured, as a means of checking the final collimator position. Elekta noted that the issue will be resolved in a future release of Desktop Pro. If you any questions related to this issue, please contact your local Elekta, third party R&V system representative or Elekta Limited at +44 (0)1293 654200.

    Distribution

    Worldwide distribution: USA including Puerto Rico and countries including: Canada and Mexico.

    Quantity

    229 units